Narrow profile composition-releasing expandable medical balloon catheter

Abstract

A process for making a folded composition-eluting balloon catheter includes coating one or both surfaces of a one or more foldable wings with a hydrophilic coating, applying a composition as a coating on the coated surface and providing the composition within a fold of the one or more foldable wings, and folding the one or more foldable wings to seal the composition by the one or more foldable wings to prevent/reduce its release until after inflation of the balloon. Another process for making a folded composition-eluting balloon catheter includes coating one or both surfaces of the one or more foldable wings with a hydrophilic coating-composition mixture and providing the composition by the one or more foldable wings, and folding the one or more foldable wings to seal the composition between the fold of the one or more foldable wings to prevent/reduce its release until after an inflation of the balloon.

What is claimed is: 
     
       1. A process for making a folded composition-eluting balloon catheter having a proximal end and a distal end, comprising an elongated catheter tube with an inflation lumen extending therewithin and at least one inflatable balloon having a central longitudinal balloon axis towards the distal end in fluid communication with the inflation lumen, wherein the balloon in an uninflated condition is configured as one or more foldable wings, wherein the balloon in a folded condition comprises a relief structure comprising at least one groove on the outside of the one or more foldable wings, configured to substantially reduce in depth in an inflated condition of the balloon, wherein the at least one groove crosses an outer edge of at least one of the one or more foldable wings, the process comprising the steps of:
 a) coating one or both surfaces of the one or more foldable wings with a hydrophilic coating such that one or both surfaces of the one or more foldable wings are provided with a coated surface; 
 b) applying a composition as a coating on the coated surface from step a), such that the composition is provided essentially exclusively within a fold of the one or more foldable wings; and 
 c) after step b), folding the one or more foldable wings around the central longitudinal balloon axis, thereby providing a folded composition-eluting balloon, 
 wherein the relief structure seals the composition between the fold of the one or more foldable wings to prevent and/or reduce a release of the composition until after an inflation of the balloon of the composition-eluting balloon catheter. 
 
     
     
       2. The process according to  claim 1 , wherein the composition is applied in a solution of an organic solvent. 
     
     
       3. The process according to  claim 2 , wherein the organic solvent comprises ethanol. 
     
     
       4. The process according to  claim 2 , wherein the organic solvent comprises at least one of methanol, propanol, acetone or ethyl acetate. 
     
     
       5. The process according to  claim 1 , wherein the composition comprises paclitaxel. 
     
     
       6. The process according to  claim 1 , wherein the composition comprises at least one of:
 one or more of paclitaxel, melatonin, thalidomide, sirolimus, zotarolimus, everolimus, biolimus, 17-13 estradiol, actinomucin D, docetaxel, and/or any derivatives thereof, or 
 one or more of cis-platin, paclitaxel, etoposide, amasecrine, teniposide, irinotecan, toptecan, doxorubicin, epirubicin, bleomycin, and/or any derivatives thereof, or 
 one or more of penicillin, erythromycin, ampicillin, clindamycin, tetracycline, streptomycin, amoxicillin, cefaclor, lincomycin, clarithromycin, cephalosporins, azithromycin, doxycycline, ciprofloxacin, cefuroxime, levofloxacin, chloramphenicol, minocycline, penicillins, vancomycin, kanamycin, gentamicins, neomycin, ceftriaxone, bacitracin, oxacillin, cloxacillin, cephalothin, amoxicillin, dicloxacillin, aminoglycosides, methicillin, carbenicillin, gentamicin, trimethoprim, oxytetracycline, rifampin, tetracyclines, polymyxins, cephalexin, chlortetracycline, metronidazole and/or any derivatives thereof. 
 
     
     
       7. The process according to  claim 1 , wherein the composition comprises paclitaxel, wherein paclitaxel is applied in a solution comprising ethanol. 
     
     
       8. The process according to  claim 1 , wherein the composition comprises a polymer, wherein a dilute first coating solution of the polymer is applied as a primer to promote adhesion of a subsequent second coating layer comprising a medicament. 
     
     
       9. The process according to  claim 1 , further comprising, after step c), the step of removing an excess amount of the composition from the coated surface of the balloon. 
     
     
       10. The process according to  claim 1 , wherein step b) comprises applying the composition to only a part of the coated surface. 
     
     
       11. The process according to  claim 1 , wherein the hydrophilic coating is at least one of polyvinylpyrrolidone (PVP) or copolymers containing N-vinylpyrrolidone, poly (meth) acrylic acid or copolymers containing (meth) acrylic acid or (meth) acrylic acid esters, polyacrylamides, polyvinylalcohol and copolymers of partially saponified vinylacetate copolymers, polyethyleneglycol, polyvinylmethylether, polyvinylmethylether-maleic anhydride and copolymers containing maleic-anhydride or maleic-acid esters or copolymers containing vinylmethylether, or copolymers thereof, or water soluble polysaccharides or derivatives thereof or xanthan or a derivative thereof. 
     
     
       12. The process according to  claim 1 , further comprising providing the folded composition-eluting balloon catheter with a stent. 
     
     
       13. The process according to  claim 12 , wherein the stent is made from one or more of stainless steel, tantalum, titanium alloy, nitinol, cobalt alloy, cobalt-chromium-nickel alloy, cobalt-chromium alloy, cobalt-chromium F562, or magnesium alloys. 
     
     
       14. The process according to  claim 1 , wherein the at least one groove has a directional component which is transverse to the central longitudinal axis of the inflatable balloon. 
     
     
       15. The process according to  claim 1 , whereby the at least one groove extends at a predetermined angle with regard to the longitudinal axis of the inflatable balloon. 
     
     
       16. The process according to  claim 1 , wherein at least two grooves extend from the distal end to the proximal end of the inflatable balloon and cross each other. 
     
     
       17. The process according to  claim 1 , wherein the at least one groove is ring or oval shaped, and has a directional component which is transverse to a central longitudinal axis of the inflatable balloon. 
     
     
       18. The process according to  claim 1 , wherein the relief structure is provided by crimping a pattern by an application of a radial pressure to an outer surface of the folded balloon. 
     
     
       19. The process according to  claim 1 , further comprising providing the composition-eluting balloon catheter with a guidewire lumen for a rapid exchange catheter or an over the wire catheter mode of operation. 
     
     
       20. A process for making a folded composition-eluting balloon catheter having a proximal end and a distal end, comprising an elongated catheter tube with an inflation lumen extending therewithin and at least one inflatable balloon having a central longitudinal balloon axis towards the distal end in fluid communication with the inflation lumen, wherein the balloon in an uninflated condition is configured as one or more foldable wings, wherein the balloon in a folded condition comprises a relief structure comprising at least one groove on the outside of the one or more foldable wings, configured to substantially reduce in depth in an inflated condition of the balloon, wherein the at least one groove crosses an outer edge of at least one folded wing, the process comprising the steps of:
 a) coating one or both surfaces of the one or more foldable wings with a mixture comprising a hydrophilic coating and a composition, such that the composition is provided essentially exclusively within a fold of the one or more foldable wings; and 
 b) after step a), folding the one or more foldable wings around the central longitudinal balloon axis, thereby providing a folded composition-eluting balloon, 
 wherein the relief structure seals the composition between the fold of the one or more foldable wings to prevent and/or reduce a release of the composition until after an inflation of the balloon of the composition-eluting balloon catheter. 
 
     
     
       21. The process according to  claim 20 , wherein the composition comprises paclitaxel, wherein paclitaxel is applied in a solution comprising ethanol. 
     
     
       22. The process according to  claim 20 , wherein the composition comprises at least one of:
 one or more of paclitaxel, melatonin, thalidomide, sirolimus, zotarolimus, everolimus, biolimus, 17-13 estradiol, actinomucin D, docetaxel, and/or any derivatives thereof, or 
 one or more of cis-platin, paclitaxel, etoposide, amasecrine, teniposide, irinotecan, toptecan, doxorubicin, epirubicin, bleomycin, and/or any derivatives thereof, or 
 one or more of penicillin, erythromycin, ampicillin, clindamycin, tetracycline, streptomycin, amoxicillin, cefaclor, lincomycin, clarithromycin, cephalosporins, azithromycin, doxycycline, ciprofloxacin, cefuroxime, levofloxacin, chloramphenicol, minocycline, penicillins, vancomycin, kanamycin, gentamicins, neomycin, ceftriaxone, bacitracin, oxacillin, cloxacillin, cephalothin, amoxicillin, dicloxacillin, aminoglycosides, methicillin, carbenicillin, gentamicin, trimethoprim, oxytetracycline, rifampin, tetracyclines, polymyxins, cephalexin, chlortetracycline, metronidazole and/or any derivatives thereof.